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'People Have a Right to Know'

The FDA has required bold new warnings about the risks of suicide in kids and teens who take antidepressants. Are adults also at risk?

Oct 27, 2004 | Newsweek

The Woodwards will never know for sure if their daughter committed suicide last year because of an adverse reaction to an antidepressant. But Tom Woodward is convinced that if he had known then about the increased risk of suicide in some young patients, it could have saved their 17-year-old’s life. “If we had been given that information in advance, I know Julie would still be here,†he says.

Julie Woodward took her life in the summer of 2003. When her parents—and others whose children had killed themselves after starting to take antidepressants—began raising questions about the deaths, their concerns helped to prompt the Food and Drug Administration (FDA) to re-examine pharmaceutical companies’ clinical trial data on antidepressants and adolescents this year. It found that, overall, children using antidepressants were nearly twice as likely to have suicidal tendencies than depressed children taking placebos.

The agency announced this month that the risk was sufficient to require a “black box†warning label on all antidepressants. A black-box label is the government’s strongest measure short of banning the drugs. The warning label describes the increased risk of suicidal thoughts and behavior in children and adolescents on antidepressant medications and notes what uses the drugs have been approved or not approved for in these patients (Prozac is currently the only medication approved to treat depression in children and adolescents.)

The FDA is also developing a patient medication guide listing the risks and precautions that will be distributed by pharmacists to patients taking the drugs.

The next question: do adults on antidepressants face similar risks? On that, the jury’s still out. “The child’s brain is at a different developmental stage than an adult’s, so you expect a different response in antidepressants, whether it’s less improvement or worse or different side effects,†says Dr. Wayne K. Goodman, who chaired the joint meeting of two federal advisory panels that called for the black-box warnings for children and teenagers. “But what’s to say that there is something magic about being 18 versus 19 years old? What is the boundary between a child and an adult?â€

That problem was underscored in February when one of the “healthy†adult participants—a 19-year-old bible-school student—hanged herself while enrolled in a clinical trial for Eli Lilly and Company’s new antidepressant, Cymbalta. The FDA has since approved Cymbalta to treat depression and diabetes-related pain. Lilly pointed out that the drug, which increases serotonin and norepinephrine levels in the brain, was tested with more than 6,000 depressed adults worldwide, and was found to be “safe and effective†overall in clinical trials. (The company didn’t study the safety or efficacy of Cymbalta in children.)

Last month, the FDA announced plans to re-examine clinical trial data for thousands of depressed adults as well to see if there's evidence that any suffered increased suicidal thoughts and behaviors while taking antidepressants. Most of the antidepressant drugs commonly used today—including Prozac, Zoloft, Paxil and Celexa—belong to a group called selective serotonin reuptake inhibitors (or SSRIs). They work by influencing levels of serotonin, the neurotransmitter that helps control moods in the brain. Others, like Serzone and Wellbutrin, target multiple receptors in the brain.

“These are serious medicines and should probably only be prescribed by practitioners willing to do the follow-up with patients and monitor them as closely as they need to be monitored,†cautions Dr. Sandra Kweder, deputy director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research. “The risk isn’t large and, by far, these medicines have helped people orders of magnitude beyond the harm they may have done. But no medicine is without risks—none.â€

Even before its black-box decision, the FDA earlier this year asked the makers of 10 leading antidepressants to include labels alerting both doctors and consumers to danger signs like agitation, anxiety or hostility in patients of all ages. But critics say such warnings can get lost in the fine print.

“Any severe risk should be spelled out,†says Vera Hassner Sharav, president of the Alliance for Human Research Protection, a patients’ rights organization. “People have a right to know. We’re not going to scare people off with a warning. It’s just to help them make a thoughtful decision—not an impetuous one based on advertising.â€

Kweder says the agency will not consider requiring the same black-box warnings for adults until it has re-evaluated the data for dozens of trials. That process is expected to take much longer than the examination of data for under-18s because there are more studies involving adults. “It could last easily a year, if not longer,†she says. “It’s a much, much bigger undertaking.â€

The FDA first investigated reports of suicide among adult antidepressant users when Prozac began to be widely used in the early 1990s. “I was hoping they would have done it [required the warning] then, but they weren’t recognizing the problem,†says Dr. Martin Teicher, director of the laboratory of developmental psychopharmacology at McLean Hospital in Belmont, Mass. In early 1990, Teicher authored a study published in the American Journal of Psychiatry describing the emergence of violent suicidal thoughts in six adults taking Prozac. Teicher’s report spurred a series of stories—and lawsuits—questioning whether the popular antidepressant was to blame for some patient suicides. But the FDA concluded that there was not sufficient evidence of a link between the two.

Since then, however, practitioners have noted increased “suicidality†(defined as suicidal thoughts or behavior) in a small number of adult patients after starting an antidepressant or altering the dosage. “"They tamper with the brain’s chemistry in ways we don’t fully understand and may be at times dangerous," says Dr. Joseph Glenmullen, a Harvard psychiatrist. "While antidepressants work in a lot of people and help a lot of people, they are very harmful to others.â€

Glenmullen wrote the critical 2001 book “Prozac Backlash" (Simon & Schuster) after observing the side effects in some of his own patients in the mid-1990s. More recently, he's investigated the risks of starting antidepressants and altering dosages for his next book, “The Antidepressant Solution: The Only Step-by-Step Guide to Safely Overcoming Antidepressant Withdrawal, Dependence, and Addiction†(Free Press) due out early next year. While he agrees there are differences between the brains of children and adults, Glenmullen dismisses claims that the risks of suicidality are limited to children as “industry spin†based on “junk science.â€
Teicher, who is now studying how depression affects the brains of patients between 18 and 22 years old, says tremendous changes in the brain do occur during childhood and early adolescence that may make younger patients more “sensitive†to the medication. Still, he says that adults are likely to face similar risks to children.

While only a small percentage might wind up with a significant adverse response, both the FDA and psychiatrists agree that all patients should be monitored closely as soon as they begin taking the antidepressants. “There has been this mistake of saying, ‘Oh, it takes three to four weeks for it to work, so give the patients the pills and have them come back three to four weeks later,’ which is really dangerous,†says Teicher.

Researchers now consider the first two weeks the riskiest time period for patients who experience adverse side effects. The Woodwards say their daughter, Julie, began acting strangely almost immediately after she started taking Zoloft—unexpectedly pushing her mother one afternoon, gnawing nervously on a napkin at the kitchen table and pacing the floors. But when her parents called the clinic that dispensed the drug, they were told not to worry because it would take a little while for Julie to adjust. Seven days after she started taking Zoloft, Julie hung herself. “We were lulled into a false sense of security. It was devastating. She had no history of self-harm or suicide. The police went through her journals and found no reference to suicide,†says Woodward, who still lives in North Wales, Pa., with his wife and three other children. “I don’t want what happened to our daughter to happen to anyone else.â€

That may be wishful thinking. But alerting both adults and children to the warning signs can only be a step in the right direction.

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